Stroke prevention devices, systems, and methods

ABSTRACT

Deflection devices, systems, and methods for the prevention of stroke. Devices hereof comprise an extension portion and an anchor portion, both of which are configured to prevent the device from advancing into the artery extending from the aortic arch in which the device may be positioned. Additionally, a retrieval system is provided, the system comprising a sleeve catheter and a retrieval device slidably disposed therein. The distal end of the retrieval device comprises one or more attachment portions configured to engage at least a portion of the anchor portion of a device positioned within an artery extending from the aortic arch.

PRIORITY

This application is related to, claims the priority benefit of, and is aU.S. continuation application of, U.S. patent application Ser. No.15/584,469 filed May 2, 2017 and issued as U.S. Pat. No. 10,695,199 onJun. 30, 2020, which (a) is related to, and claims the priority benefitof, U.S. patent application Ser. No. 14/546,601, filed Nov. 18, 2014 andissued as U.S. Pat. No. 9,636,204 on May 2, 2017, which is related to,and claims the priority benefit of, U.S. Provisional Patent ApplicationSer. No. 61/905,509, filed Nov. 18, 2013, and (b) is related to, claimsthe priority benefit of, and is a U.S. continuation-in-part applicationof, U.S. patent application Ser. No. 15/377,103, filed Dec. 13, 2016,which is related to, claims the priority benefit of, and is a U.S.continuation application of, U.S. patent application Ser. No.13/264,508, filed Oct. 14, 2011 and issued as U.S. Pat. No. 9,517,148 onDec. 13, 2016, which is related to, and claims the priority benefit of,International Application Serial No. PCT/US10/31475, filed Apr. 16,2010, which is related to, and claims the priority benefit of, U.S.Provisional Patent Application Ser. No. 61/169,767, filed Apr. 16, 2009.The entire contents of the aforementioned priority and relatedapplications are hereby incorporated by reference in their entirety intothis disclosure.

BACKGROUND Stroke

A stroke is defined as a rapidly developing loss of brain function dueto a disturbance in the blood supply to the brain. This can be due toischemia (lack of blood supply) caused by thrombosis or embolism or dueto a hemorrhage. As a result, the affected area of the brain is unableto function, leading to the inability to move one or more limbs on oneside of the body, the inability to understand or formulate speech, orthe inability to see one side of the visual field amongst others.

Each year, about 800,000 people experience a new or recurrent stroke.Approximately 600,000 of these are first attacks, and 200,000 arerecurrent attacks. In addition, and on average, someone in the U.S. hasa stroke every 40 seconds, and each year, about 55,000 more women thanmen have a stroke. On average, every 3-4 minutes, someone dies of astroke. Because women live longer than men, more women than men die ofstroke each year. Women accounted for 60.6% of U.S. stroke deaths in2005. Men stroke incidence rates are greater than women at younger agesbut not at older ages. Despite advances in stroke prevention treatments,the incidence of hospitalized stroke and case fatality did not decrease.African-Americans have almost twice the risk of first-ever stroke thanwhites. The age adjusted stroke incidence rates in people 45-84 years ofage are 6.6 per 1000 population in black men, 3.6 in white men, 4.9 inblack women, and 2.3 in white women.

Of all strokes, 87% are ischemic, 10% are intracerebral hemorrhage, and3% are subarachnoid hemorrhage strokes. Stroke accounted for about 1 outof every 17 deaths in the U.S. in 2005, and approximately 53% of strokedeaths in 2005 occurred out of the hospital.

Total stroke mortality in 2005 was about 150,000. The 2005 overall deathrate for stroke was 46.6 per 100,000. Death rates were 44.7 for whitemales, 70.5 for black males, 44.0 for white females, and 60.7 for blackfemales, all per 100,000. When considered separately from othercardiovascular diseases, stroke ranks no. 3 among all causes of death,behind heart disease and cancer.

A report released by the Centers for Disease Control (CDC) incollaboration with the Centers for Medicare and Medicaid Services (CMS),the Atlas of Stroke Hospitalizations Among Medicare Beneficiaries, foundthat in Medicare beneficiaries, 30-day mortality rate varied by age: 9%in patients 65 to 74 years of age, 13.1% in those 74 to 84 years of age,and 23% in those 85 years of age.

Atrial Fibrillation

Atrial fibrillation (AF) is a significant, independent risk factor forischemic stroke, increasing risk about 5-fold. The percentage of strokesattributable to AF increases steeply from 1.5% at 50 to 59 years of ageto 23.5% at 80 to 89 years of age. Most strokes in patients with AF arecardioembolic caused by embolism of left atrial appendage thrombi, butsome are caused by coexisting intrinsic cerebrovascular diseases intypically elderly, often hypertensive patients.

AF carries an annual risk of thromboembolic complications of 3-6%, whichis 5-7 times greater than that of controls with sinus rhythm. AF ispresent in 15-21% of patients affected by stroke. AF/flutter, a strongrisk factor for stroke, is arguably the most important finding oncardiac workup in patients with ischemic stroke. Once identified,introduction of oral anticoagulant therapy (warfarin, for example)provides a 40% risk reduction in recurrent stroke compared withantiplatelet therapy. Ischemic stroke with AF is associated with greaterdisability and mortality than those without AF. However, not allpatients can receive anticoagulant or antiplatelet therapies, and thesame or other patients may be prone to clots that form in the leftatrial appendage and enter the bloodstream, so other types of therapieswould be required.

Patients with AF have an increased risk of major, disabling stroke,often caused by large infarctions in the middle cerebral arteryterritory. Some studies showed that AF was associated with an increasedrisk of death in the first four weeks after stroke likely due to theadvanced age in stroke patients with AF, large infarction, severeneurological deficits, and poor functional outcomes.

First, strokes in patients with AF may largely be cardioembolic, whichcauses a sudden occlusion of large cerebral arteries without sufficientcollateral blood flow, resulting in more severe strokes. Several studieshave reported that stroke patients with AF often have large corticalinfarcts on computed tomography, and less frequently have lacunarinfarction as compared with patients without AF.

Heart Failure

Patients with heart failure (HF) are at increased risk forthromboembolic events. Left ventricular (LV) thrombus provides asubstrate for events and a rationale for anticoagulation.Echocardiography studies have yielded conflicting results, however,regarding thrombus prevalence. Among populations with similar degrees ofsystolic dysfunction, studies have reported over a 20-fold difference inprevalence, ranging from 2.1% to 50%. Moreover, when thrombus isidentified, conflicting findings have been reported concerning the riskof future embolic events.

The impact of nonrheumatic atrial fibrillation, hypertension, coronaryheart disease, and cardiac failure on stroke incidence was examined inthe Framingham Study. Compared with subjects free of these conditions,the age-adjusted incidence of stroke was more than doubled in thepresence of coronary heart disease and more than tripled in the presenceof hypertension. There was a more than fourfold excess of stroke insubjects with HF and nearly fivefold increase when atrial fibrillationwas present. In persons with coronary heart disease or HF, atrialfibrillation doubled the stroke risk in men and tripled the risk inwomen. Factors that predispose to thromboembolic events in patients withHF include low cardiac output, with relative stasis of blood in dilatedcardiac chambers, poor contractility and regional wall motionabnormalities and concomitant atrial fibrillation.

BRIEF SUMMARY

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device comprises an extensionportion, an anchor portion, and two or more parallel, convex struts. Theextension portion has a first end and a second end and is sized andshaped to fit within an artery extending from an aortic arch. The anchorportion comprises a plurality of wings and is coupled with the secondend of the extension portion and sized and shaped to prevent the devicefrom advancing into the artery extending from the aortic arch in whichthe first end of the extension portion may be positioned. In at leastone embodiment, the anchor portion comprises a flange configuration.Alternatively, the anchor portion may comprise two or more wings.

The two or more parallel convex struts of the device are positionedacross an opening defined within the second end of the extensionportion, the two or more parallel convex struts configured to divert anembolus from entering the artery when the first end of the extensionportion is positioned within the artery. In another embodiment, the twoor more parallel convex struts comprise four or more parallel convexstruts. In an exemplary embodiment, when the device is positioned withinthe artery extending from an aortic arch, the two or more parallelconvex struts are positioned either approximately perpendicular to, in adirection of (i.e. approximately parallel with), or in an oblique mannerrelative to, blood flow within the aortic arch. In an additionalembodiment, the device comprises a stent. In yet an additionalembodiment, the anchor portion is autoexpandable from a collapsedconfiguration to an expanded configuration.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the extension portion comprises asubstantially cylindrical shape. In another embodiment, the extensionportion comprises an extension mesh comprising multiple wires. In yetanother embodiment, the extension portion has a length between about 1.5cm to about 2.5 cm. In an additional embodiment, the extension portionhas a diameter between about 6 mm to about 8 mm when the extensionportion is in an expanded configuration. In yet an additionalembodiment, the extension portion has a diameter between about 1.8 mm toabout 2.0 mm when the extension portion is in a compressedconfiguration.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device is comprised of a materialselected from the group consisting of stainless steel,cobalt-chromium-nickel-molybdenum-iron alloy, tantalum, nitinol,nickel-titanium, polymer materials, and a shape-memory polymer.

In at least one exemplary embodiment of a device for the prevention ofstroke of the present disclosure, the device further comprises one ormore radiopaque markers positioned upon at least one of the anchorportion, such as at one or more of the plurality of wings. In anadditional embodiment, the one or more radiopaque markers are positionedrelative to the two or more parallel convex struts. In yet additionalembodiments, when the first end of the extension portion is positionedwithin the artery extending from an aortic arch, the one or moreradiopaque markers facilitate alignment of the device so that the two ormore parallel convex struts are positioned either approximatelyperpendicular to, or in a direction of (i.e. approximately parallelwith), or in an oblique manner relative to, blood flow within the aorticarch. In at least one exemplary embodiment of a device for theprevention of stroke of the present disclosure, the diameter of each ofthe two or more parallel convex struts is between about 0.25 mm andabout 1.0 mm, inclusive. In another embodiment, the two or more parallelconvex struts are positioned between about 0.75 mm to about 1.0 mm,inclusive, from one another. In yet another embodiment, the two or moreparallel convex struts are flexible. In various embodiments, each wingof the plurality of wings comprises a wire forming a loop relative tothe second end of the extension portion. In at least one embodiment, theextension portion comprises a stent frame without an extension meshcoupled thereto or formed therein. In various embodiments, the stentframe comprises a plurality of extension struts connected to one anotherby way of one or more connection struts.

In at least one exemplary embodiment of a retrieval system for theprevention of stroke of the present disclosure, the system comprises atleast one device for the prevention of stroke, a sleeve catheter and aretrieval device. The at least one device comprises an extension portionhaving a first end and a second end (the extension portion sized andshaped to fit within an artery extending from an aortic arch), an anchorportion comprising a plurality of wings and coupled with the second endof the extension portion (the anchor portion sized and shaped to preventthe device from advancing into the artery extending from the aortic archin which the first end of the extension portion may be positioned), andtwo or more parallel convex struts positioned across an opening definedwithin the second end of the extension portion, the two or more parallelconvex struts configured to divert an embolus from entering the arterywhen the first end of the extension portion is positioned within theartery. The sleeve catheter is configured for intravascular insertionand advancement, the sleeve catheter comprising a proximal end, an opendistal end, and a lumen extending therebetween, and the retrieval deviceslidably disposed within the lumen of the sleeve catheter, the retrievaldevice comprising a proximal end for manipulation by a user and a distalend comprising one or more second attachment portions, wherein each ofthe one or more second attachment portions of the retrieval device areconfigured to engage the first attachment portion of the anchor portionof the device. In another embodiment, the system further comprises aconical dilator sized and shaped to slidingly engage the hypotube. Inyet another embodiment, the conical dilator comprises a tapered distaland a proximal end. In an additional embodiment, the folder has an innerdiameter, and wherein the tapered distal end of the conical dilator issized and shaped to fit within the inner diameter of the folder. In yetan additional embodiment, when the device is positioned within theartery extending from an aortic arch, the two or more parallel convexstruts either approximately perpendicular to, in a direction of (i.e.approximately parallel with), or in an oblique manner relative to, bloodflow within the aortic arch. In another embodiment, the retrieval deviceof the system comprises one or more wires. In yet other embodiments, thesystem comprises two devices for prevention of a stroke. Furthermore, inat least one embodiment, the first attachment portion of the anchorportion comprises a screw tip and a first magnet and the secondattachment portion of the retrieval device comprises a screw hole and asecond magnet, and the screw tip and the first magnet of the firstattachment portion are configured to securely engage with the screw holeand the second magnet of the second attachment portion, respectively.Additionally, in other embodiments, the second attachment portion of theretrieval device comprises a lace component and the first attachmentportion of the anchor portion comprises a hook tip configured to engagethe lace component of the retrieval device.

In at least one exemplary embodiment of a method for preventing strokeof the present disclosure, the method comprises the steps of introducinga device for preventing stroke into a body, navigating the device withinthe body until the device reaches an aortic arch, and positioning thedevice within a first vessel branching from the aortic arch so that thetwo or more convex struts are positioned either approximatelyperpendicular to, or in a direction of (i.e. approximately parallelwith), or in an oblique manner relative to, blood flow within the aorticarch. In another embodiment, in the step of introducing a device forpreventing stroke into a body, the device comprises an extension portionhaving a first end and a second end, an anchor portion comprising aplurality of wings and coupled with the second end of the extensionportion and sized and shaped to prevent the device from advancing intothe artery extending from the aortic arch in which the first end of theextension portion may be positioned, and two or more convex strutspositioned across an opening defined within the second end of theextension portion. Here, the extension portion may be sized and shapedto fit within an artery extending from the aortic arch and/or the two ormore convex struts of the device may be configured to divert an embolusfrom entering the artery when the first end of the extension portion ispositioned within the artery. In yet another embodiment, the step ofpositioning the device is performed by aligning the device within thevessel by detecting one or more radiopaque markers positioned upon thedevice. Furthermore, placement of the device within the first vesseldoes not significantly affect upstream blood flow patterns. In anadditional embodiment, the step of positioning the device comprisespositioning the device within an innominate artery.

In at least one exemplary embodiment of a method for preventing strokeof the present disclosure, the method further comprises the steps ofintroducing a second device for preventing stroke into the body;navigating the second device within the body until the second devicereaches the aortic arch; and positioning the second device within asecond vessel branching from the aortic arch. In this manner, two ormore convex struts of the second stent are positioned eitherapproximately perpendicular to, in a direction of (i.e. approximatelyparallel with), or in an oblique manner relative to, blood flow withinthe aortic arch. In another embodiment, the step of positioning thesecond device comprises positioning the second device within a commoncarotid artery. In yet another embodiment, the step of positioning thefirst device comprises positioning the first device within an innominateartery, wherein the first device is capable of diverting an embolus fromentering the innominate artery and the second device is capable ofdiverting the embolus from entering the common carotid artery.

In at least one exemplary embodiment of a method for preventing strokeof the present disclosure, the method further comprises the step ofanchoring the device within the first vessel by deploying the extensionportion and the anchor portion of the device. Additionally, the step ofanchoring the device within the first vessel may further comprise movingthe extension portion from a collapsed position to an expanded positionand moving the anchor portion from a collapsed position to an expandedposition. In yet another exemplary embodiment of the method forpreventing stroke of the present disclosure, the method furthercomprises the steps of retrieving the stent from the first vessel andremoving the stent from the body. In an additional embodiment, the stepsof retrieving the stent from within the first vessel and removing thestent from the body further comprise the steps of: introducing aretrieval system into the body, navigating the sleeve catheter withinthe body until the open distal end of the sleeve catheter reaches anaortic arch, advancing the distal end of the retrieval catheter throughthe open distal end of the sleeve catheter so that the one or moreattachment portions engage the anchor portion of the device, disengagingthe device from the first vessel, and withdrawing the device and theretrieval system from the body. In yet another embodiment of the method,the step of introducing a retrieval system into the body furthercomprises the retrieval system comprising a sleeve catheter configuredfor intravascular insertion and advancement, the sleeve cathetercomprising a proximal end, an open distal end, and a lumen extendingtherebetween, and a retrieval device slidably disposed within the lumenof the sleeve catheter, the retrieval device comprising a proximal endfor manipulation by a user and a distal end comprising one or moreattachment portions, each of which are configured to engage the anchorportion of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a diagram of at least a portion of an aorta, according tothe present disclosure;

FIGS. 2A and 2B show exemplary embodiments of a device for theprevention of stroke, according to the present disclosure;

FIG. 2C shows an embodiment of a device comprising a planar flange,according to the present disclosure;

FIGS. 3A and 3B show side views of an embodiment of a device comprisingtwo or more wings, according to the present disclosure;

FIG. 3C shows an interior view of the device of FIGS. 3A and 3B;

FIG. 4 shows a side view of an embodiment of a device for the preventionof stroke comprising a stent frame according to the present disclosure;

FIG. 5A shows exemplary devices for the prevention of stroke positionedwithin arteries extending from a portion of an aorta with the convexstruts in alignment with blood flow, according to the presentdisclosure;

FIG. 5B shows exemplary devices for the prevention of stroke positionedwithin arteries extending from a portion of an aorta with the convexstruts in alignment approximately perpendicular to blood flow, accordingto the present disclosure;

FIG. 6A shows an exemplary embodiment of a system for preventing stroke,according to the present disclosure;

FIG. 6B shows an exemplary embodiment of a system for preventing stroke,the system comprising a device having two or more wings, according tothe present disclosure;

FIGS. 7A and 7B show an exemplary system of the present disclosure withportions thereof being moved to allow for device deployment, accordingto the present disclosure;

FIGS. 8A and 8B show at least a portion of an exemplary system forpreventing stroke, said system comprising a conical dilator useful tofacilitate removal of at least a portion of the exemplary system fromthe body, according to the present disclosure;

FIGS. 9A and 9B show additional embodiments of an exemplary system forpreventing stroke, according to the present disclosure;

FIGS. 10A-10E show various steps of a method for positioning a devicewithin a body, according to the present disclosure;

FIGS. 11A-11C show various steps of a method for retrieving a devicepreviously positioned within a body, according to the presentdisclosure;

FIG. 12 shows at least a portion of an exemplary system for retrievingtwo devices previously positioned within arteries extending from aportion of an aorta, according to the present disclosure;

FIGS. 13A and 13B show embodiments of an attachment portion of theexemplary system for retrieving a device previously positioned within abody; and

FIG. 14 shows a flow chart of an exemplary method for preventing strokeaccording to the present disclosure.

An overview of the features, functions and/or configurations of thecomponents depicted in the various figures will now be presented. Itshould be appreciated that not all of the features of the components ofthe figures are necessarily described. Some of these non-discussedfeatures, such as various couplers, etc., as well as other discussedfeatures, are inherent from the figures themselves. Other non-discussedfeatures may be inherent in component geometry and/or configuration.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended. Furthermore,numerous specific details are set forth in order to provide a thoroughunderstanding of the present disclosure. Particular examples may beimplemented without some or all of these specific details. In otherinstances, well known devices or processes have not been described indetail so as to not unnecessarily obscure the present disclosure.

Various systems, methods and techniques of the present disclosure willsometimes describe a connection between two components. Words such asattached, affixed, coupled, connected, and similar terms with theirinflectional morphemes are used interchangeably, unless the differenceis noted or made otherwise clear from the context. These words andexpressions do not necessarily signify direct connections, but includeconnections through mediate components and devices. It should be notedthat a connection between two components does not necessarily mean adirect, unimpeded connection, as a variety of other components mayreside between the two components of note. Consequently, a connectiondoes not necessarily mean a direct, unimpeded connection unlessotherwise noted. Furthermore, wherever feasible and convenient, likereference numerals are used in the figures and the description to referto the same or like parts or steps. Additionally, the drawings are in asimplified form and not to precise scale.

The disclosure of the present application provides various devices,systems, and methods for the prevention of stroke. The devices, systems,and methods disclosed herein facilitate stroke prevention, in part, byaddressing specific areas of the heart and diverting the trajectories ofblood clots away therefrom with minimal to no influence on resistance ofblood flow through such areas and/or significantly affect upstream bloodflow patterns.

A diagram of at least a portion of an exemplary aorta is shown inFIG. 1. An aorta 100 is the main trunk of a vascular system whichconveys oxygenated blood to the tissues of a body. It begins at theupper part of the left ventricle, where it may be approximately 3 cm indiameter in an adult human. As shown in FIG. 1, and at the union of theascending aorta 102 with the aortic arch 104 (or the “arch of aorta”),the caliber of the vessel is increased, owing to a bulging of its rightwall. This dilatation is termed the aortic bulb 106 (or bulb of theaorta), and on transverse section shows a somewhat oval figure. Theascending aorta 102 is contained within the pericardium and is enclosedin a tube of the serous pericardium. It ascends for a short distance(the ascending aorta 102 is about 5 cm in length in an adult human),arches backward, and then descends within the thorax and abdomen (thedescending aorta 108) and ends into the right and left common iliacarteries (about 1.7 cm in diameter in an adult human). The rightcoronary 110 and the left coronary 112, as shown in FIG. 1, branch fromthe ascending aorta 102.

There are three arteries that branch from the aortic arch 104, namelythe innominate artery 114, the left common carotid artery 116, and theleft subclavian artery 118. Instead of arising from the highest part ofthe aortic arch 104, these branches may spring from the commencement ofthe aortic arch 104 or the upper part of the ascending aorta 102. Thedistance between the aortic arch 104 or the upper part of the ascendingaorta 102 at their origins may be increased or diminished, the mostfrequent variation being the approximation of the left common carotidartery 116 toward the innominate artery 114. In addition, and as shownin FIG. 1, the innominate artery 114 branches into the right subclavianartery 120 and the right common carotid artery 122.

Ischemic strokes, the most common type of stroke, occur when blood clotsor other debris are swept through the bloodstream and lodge in one ormore of the aortic branches 114, 116. As the innominate and left commoncarotid arteries 114, 116 ultimately supply blood to the brain, thepartial or complete blockage thereof reduces or inhibits blood flow tothe brain, thus increasing the risk of ischemic stroke. Ejectiondynamics of blood clots from the left ventricle is diverse and random,with clots having different release velocities at different stages ofthe cardiac cycle. Furthermore, blood clots can vary in size—typicallyin the range of about 2 mm to about 6 mm—which can also have asignificant effect on clot velocity and their flow patterns as theyleave the heart. In addition, the hemodynamics in the aortic arch 104are typically characterized as complex flow patterns due to the archcurvature and branches 114, 116. Accordingly, clot trajectory is acomplex function of aortic flow conditions, discrete phase behavior ofclots, and their dynamic interactions. To prevent ischemic stroke, notonly must clots be prevented from lodging within the aortic branches114, 116, but the solution must be mindful of the complexity of theaortic flow field and not generate a substantial resistance to flowtherethrough.

The devices, systems, and methods of the present application areconfigured to maintain a balance between efficacy in deflecting bloodclots from an artery extending from the aortic arch 104 and affectingminimal influence on resistance to blood flow therethrough. In thismanner, such deflection devices, systems and methods can ensurediversion of blood clots away from the aortic branches 114, 116, ratherthan blocking clots on the device and thereby obstructing the underlyingarteries. FIGS. 2A-2C show exemplary embodiments of a device of thepresent application for the prevention of stroke. In application, suchdevice (and any embodiments thereof) may be used with one or more of theaortic branches 114, 116, 118 to deflect the trajectory of blood clotsdestined for the structures of the aorta 100 with negligible change inblood flow resistance. As shown in FIG. 2A, an exemplary device 200 maycomprise a stent comprising an extension portion 202 and a flangeportion 204. Extension portion 202, as shown in FIG. 2A, may comprise acylindrical stent sized and shaped to fit securely within an aorticbranch. An exemplary extension portion 202 may comprise, for example,extension mesh 206 comprising multiple wires as shown in FIG. 2A. Flangeportion 204 may comprise an inner diameter (shown as D1 in FIG. 2A) andan outer diameter (shown as D2), whereby D2 is larger than D1. In atleast one embodiment, device 200 is collapsible, similar to atraditional stent. Alternatively or additionally, the device 200 (orindependent components thereof) may be autoexpandable to facilitatesecure anchoring within an artery and/or the long term stability of thedevice 200 after placement.

In at least one embodiment of device 200 of the disclosure of thepresent application, device 200 comprises an autoexpandable metallicstent comprising a proximal flange (flange portion 204) and a distalcylindrical tube (extension portion 202). In an exemplary embodiment,extension portion 202 is approximately 1.0 cm to 2.5 cm in length. In atleast one embodiment of device 200, the diameter of the stent isapproximately 6 to 8 mm. Suitable material for a device 200 includes butis not limited to, stainless steel,cobalt-chromium-nickel-molybdenum-iron alloy, tantalum, nitinol,nickel-titanium, polymer materials, and various shape-memory polymersknown in the art, including polyurethane, polytetrafluoroethylene orpolytetrafluoroethene (PTFE), or another synthetic material.

Flange portion 204, as shown in the exemplary embodiments shown in FIGS.2A and 2B, comprises flange mesh 208 comprising multiple wires. Inanother embodiment, and as shown in FIG. 2C, flange portion 204comprises a planar flange 210 comprised of metal, plastic, or any othermaterial suitable for such a flange portion 204. The flange portion 204may comprise any length and/or diameter that is effective to impede theprogression of the device 200 within an artery when positioned within abody. In at least one embodiment, the flange portion 204 is betweenabout 3 mm and about 5 mm in length. Furthermore, the flange portion 204may be configured to move between a collapsed position having a smallerdiameter for delivery and/or retrieval of the device 200 (see FIG. 6A)and an expanded position having a larger diameter (see FIG. 2A). Forexample, in at least one embodiment, the flange portion 204 is comprisedof an autoexpandable material such that when the flange portion 204 isreleased from a delivery mechanism, it automatically moves into theexpanded position to assist in anchoring the device 200 within an arteryof interest. As shown in FIGS. 2A-2C, the device 200 also comprises twoor more convex struts 212 operable to divert, for example, an embolus,from entering the inner portion of device 200 (the inner portion definedby extension portion 202) while still allowing blood to flowtherethrough without significantly affecting flow resistance. Convexstruts 212 are one example of such an embolus diversion portion ofdevice 200, noting that other embodiments of an embolus diversion notcomprising convex struts 212 may be useful with device 200. For example,and instead of convex struts 212, an exemplary embolus diversion portionmay comprise a mesh (similar to, for example, extension mesh 206 and/orflange mesh 208), whereby such a mesh is operable to divert an embolusfrom entering the inner portion of device 200.

Convex struts 212, in an exemplary embodiment, are positioned alongdevice 200 to cover the proximal orifice of the cylindrical stent(device 200). In at least one embodiment of a device 200 of thedisclosure of the present application, the diameter of each convex strut212 is approximately 0.25 mm to 1.0 mm, and the distance between eachconvex strut 212 is approximately 0.75 mm to 1.0 mm. In at least oneexemplary embodiment, the diameter of each convex strut 212 isapproximately 0.75 mm and the distance between each convex strut 212 isapproximately 0.75 mm, which has been found to provide beneficialdeflection efficacy with respect to emboli while affecting onlynegligible change in flow resistance through the underlying artery.

It will be appreciated that the number of convex struts 212 present onthe device 200 may be customized according to a user's preferencesand/or patient specifications. Furthermore, each convex strut 212 of thedevice 200 need not be configured identically; indeed, device 200 may beconfigured to employ various combinations of convex strut 212 diameter,intervals, and heights. Moreover, the convex struts 212 may alsocomprise varying cross-sectional areas and/or a non-spherical profile ofthe convex envelope. Convex struts 212 may comprise material the sameand/or similar to the material used to prepare other portions of device200, and may also be a combination of a metal plus polyurethane,polytetrafluoroethylene or polytetrafluoroethene (PTFE), or anothersynthetic material.

In at least one embodiment, convex struts 212 may be semi-rigid orflexible in order to allow the removal of a hypotube 402 (see FIGS.6A-7B) and/or allow the passage of a catheter stent device, includingdevice 200, for stenting the carotid artery, for example, if it developsan atherosclerotic plaque. In an exemplary embodiment, the strut shapecan be convex or semi-convex in order to be easily and constantly“washed” by the aortic blood flow and therefore avoid local thrombosis.If an embolus lands on a strut, the strut shape will also allow it towash off to the periphery not only preventing the embolus from enteringthe brain vascular system, but also deflecting the embolus away from theostium of the artery to ensure the blood flow therethrough does notbecome restricted or blocked (i.e. the embolus does not stick to theconvex struts 212, but rather deflects off).

In addition, and in the exemplary embodiment shown in FIG. 2B, device200 may further comprise one or more radiopaque markers 214 locatedproximally and/or distally on device 200 to aid the placement of device200 within a body. For example, in at least one embodiment, one or moreradiopaque markers 214 are positioned on the flange portion 204 in alocation(s) relative to the convex struts 212 of the device 200.Accordingly, when the device 200 is positioned within an artery, the oneor more markers 214 on the device 200 can be visualized to identify theorientation of the convex struts 212 relative to the direction of theblood flow.

Now referring to FIGS. 3A-3C, an additional exemplary embodiment of thedevice 200 is shown. As illustrated in FIG. 3A, in this embodiment,instead of the mesh or planar flange portion 204, the device 200comprises two or more wings 304 extending from the extension portion202. In at least one embodiment, each of the wings 304 is defined by awire 303. As shown in FIG. 3A, for example, each wing 304 (or wire 303of each wing 304) extends from a second end 292 of extension portion202, noting that extension portions 202 referenced herein have a firstend 290 (as shown in FIG. 3A, for example) configured to extend within avessel, and a second end 292 at the location of the various struts 212and/or wings 304. Each wing 304 of the plurality of wings 304, forexample, may comprise a wire 303 forming a loop relative to the secondend 292 of the extension portion 202. The plane of each wing 304 may beleft as an open space (as shown in FIGS. 3A-3C), or covered by a mesh orany other suitable material. When the embodiment of the device 200having two or more wings 304 is positioned within a body, the wings 304contact the underlying tissue at intervals, thereby utilizing aminimized structure to hold the device 200 in place as compared to thedevice 200 comprising the flange portion 204.

Similar to the flange portion 204, wings 304 of the device 200 are sizedand configured to impede the progression of the device 200 within anartery when positioned within a body. Additionally, when the device 200is placed within a proximal opening of the innominate artery 114 or theleft common carotid artery 116, the wings 304 may further provide asupport structure over the aortic wall of the aortic arch 104 at theentrance of the supra-aortic branches 114, 116. The wings 304 may bebetween about 3 mm and about 5 mm in length. As shown in FIGS. 3A-3C,wings 304 may comprise a petal configuration; however, it will be notedthat any suitable shape or configuration any be employed and that eachwing 304 of the device 200 need not have the same length and/orconfiguration. In addition, in the exemplary embodiment shown in FIG.3C, the wings 304 of the device 200 may further comprise one or moreradiopaque markers 214.

Similar to the flange portion 204, the wings 304 are configured to movebetween a collapsed position having a smaller overall diameter (see FIG.6B) and an expanded position having a larger overall diameter D (seeFIG. 3B). In at least one embodiment, each of the wings 304 are hingedlycoupled with the extension portion 202 and biased to the expandedposition. As such, when the wings 304 are not held in the collapsedposition, the wings 304 automatically move to the expanded position. Asdescribed in further detail herein, movement of the wings 304 betweenthe collapsed and expanded positions facilitates delivery/retrieval andthe long term stability of the device 200 within an artery.

FIG. 4 shows yet another exemplary embodiment of the device 200. Asillustrated in FIG. 4, the extension portion 202 of the device 200 mayalternatively comprise a stent frame 310 without the inclusion ofextension mesh or other materials thereon. In this embodiment of thedevice 200, the extension portion 202 has significantly less structurethan the embodiment shown in FIG. 2A. As with the previously describedembodiments, the stent frame 310 may comprise an autoexpandable metallicstent capable of radial expansion such that, when deployed within anartery, the stent frame 310 anchors the device 200 therein by way ofradial force. While the embodiment of FIG. 4 comprises wings 304, itwill be appreciated that a device 200 comprising the stent frame 310 mayalternatively comprise the flange portion 204 or any other componentdescribed herein. Exemplary stent frames 310, such as shown in FIG. 4,may comprise a plurality of extension struts 311 positioned around arelative perimeter or circumference of device 200 (such as around theopening where convex struts 212 are located), extending from second end292 toward first end 290, and may be connected to one another using oneor more connection struts 313, which may be curved as desired as shownin FIG. 4.

Exemplary devices for the prevention of stroke positioned within aportion of an aorta are shown in FIGS. 5A and 5B. While the devices 200illustrated in FIGS. 5A and 5B both comprise a flange portion 204 and anextension portion 202 having extension mesh 206, it will be understoodthat any embodiments of the device 200 of the present disclosure can bepositioned pursuant to and are capable of the same functionalitydescribed in connection with FIGS. 5A and 5B.

As shown in FIGS. 5A and 5B, two devices 200 are positioned withinarteries branching from aorta 100, with one device 200 positionedpartially within innominate artery 114 and another device 200 positionedpartially within left common carotid artery 116. Device 200 withininnominate artery 114 is positioned such that extension portion 202 ispositioned within a portion of innominate artery 114 extending fromaortic arch 104 and flange portion 204 prevents device 200 fromadvancing further into innominate artery 114. Similarly, a device 200 isshown in FIGS. 5A and 5B positioned within left common carotid artery116 such that extension portion 202 is located within a portion of leftcommon carotid artery 116 extending from aortic arch 104 and flangeportion 204 prevents device 200 from advancing further into left commoncarotid artery 116. In at least one embodiment, flange portion 204completely covers and exceeds the size of the entrance of the artery inwhich device 200 is positioned. In an exemplary embodiment of device 200positioned within an artery as referenced herein, the distal cylindricalportion of the stent (extension portion 202 of device 200) additionallyor alternatively anchors device 200 by applying radial force to thearterial walls of the artery in which device 200 is placed. In thismanner, both the extension portion 202 and the flange portion 204 mayact to anchor the device 200 in place when positioned within an artery.

As shown in the exemplary embodiments of device 200 shown in FIG. 5A,convex struts 212 are aligned in a direction similar to the flow ofblood within aorta 100. In such an alignment, and as blood flows throughaorta 100, an embolus 300 present within aorta 100 (specifically withinthe aortic arch 104) would be guided by the blood flow along convexstruts 212 and across the proximal opening of the aortic branch. Asshown in FIG. 5B, the convex struts 212 of both devices 200 are alignedin a direction approximately perpendicular to the flow of blood withinaorta 100. In such an alignment, an embolus 300 present within aorta 100would contact convex struts 212 and be deflected therefrom with littleor no risk of embolus 300 being trapped therein. As referenced herein,convex struts 212 may also be positioned in the direction of (i.e.,approximately parallel with), or in an oblique manner relative to, bloodflow within the aortic arch 104 as shown in FIG. 5A. In application, thedevice 200 may be positioned within an artery to achieve any orientationof the convex struts 212 relative to the flow field that may be desiredin accordance with patient specifications and/or user preference.

Positioning the devices 200 as shown in FIGS. 5A and 5B prevents anembolus 300 from entering the innominate artery 114 and the left commoncarotid artery 116, but allows the embolus 300 to enter the leftsubclavian artery 118. Because the innominate and left common carotidarteries 114, 116 supply blood flow to the brain, in this example, thedevices 200 thus prohibit the embolus 300 from advancing to the brainvascular system, thereby significantly reducing a patient's risk ofischemic stroke. Instead, the embolus 300 is allowed to flow into otherarteries—such as the femoral or iliac arteries, for example—where suchembolus 300 can be filtered from or sucked out of the blood stream usingan appropriate medical procedure. In other words, such an arrangement ofdevices 200 may effectively prevent a patient from having a stroke bydeflecting any embolus 300 present in the blood stream away from thevessels that feed the brain and instead routing such emboli 300 to alocation where they may be easily and safely removed.

In summary, and as described above with respect to FIGS. 5A and 5B, forexample, the present disclosure provides a device 200, which may bereferred to as a percutaneous carotid emboli rerouting device,configured for individual delivery to an artery given off by the aorticarch 104 (namely the innominate artery 114, the left common carotidartery 116, and the left subclavian artery 118) to avoid the passage ofembolic or thromboembolic material (an embolus 300, which may be, forexample, a clot, calcium, etc.) to the brain vascular system.Furthermore, the present disclosure provides for the provision of morethan one of these devices 200 to the arteries off the aortic arch 104such that an arrangement of devices 200 prevents thromboembolic strokein patients with different cardiovascular diseases from cardiac origin.

At least one goal of the devices, systems, and methods of the presentdisclosure is to reroute an embolus distally to the arterial system(iliac or femoral arteries) to avoid disabling stroke, decreasemortality and avoid physical impairment with a poor quality of life. Aspreviously mentioned, unlike stroke, medical or surgical treatment ofthe peripheral arterial embolus (fibrinolitic drugs, surgicalembolectomy, or endovascular embolus suction) can be provided withlittle residual effect. This may be particularly useful to patients whohave undergone medical procedures associated with a high risk of strokeand/or blood clots being released following the procedures (e.g,transcatheter aortic valve implantation (“TAVI”), mitral valvereplacement, calcific mitral valve insufficiency, balloon dilation,etc.). For example, the general risk of stroke after TAVI is about threepercent (3%), which increases to about six to ten percent (6-10%) thirtydays following the procedure, and again to about seventeen totwenty-four percent (17-24%) one year following the procedure. As such,while TAVI (or similar procedures) is often used to repair a patient'sheart and/or circulatory system, the procedure often results in braindamage due to its side-effect of increasing the occurrence of bloodclots.

The devices, systems and methods of the present disclosure can be usedin connection with such patients to divert the resulting clots.Moreover, the devices, systems and methods described herein are alsoparticularly applicable to patients who cannot receive anticoagulants,are prone to clots forming in the left atrial appendage and entering thebloodstream, or simply present an elevated risk for brain damage due tostroke. The risk of brain damage can also generally be reduced with theelderly by employing the devices, systems and methods disclosed herein.

Exemplary embodiments of a system for preventing stroke of the presentdisclosure is shown in FIGS. 6A and 6B. As shown in FIGS. 6A and 6B,system 400 comprises a hypotube 402 having a distal end and a proximalend, and in at least one exemplary embodiment, hypotube 402 comprises afolder 404 coupled to the distal end of hypotube 402. In the embodimentshown in FIG. 6A, system 400 further comprises a device 200, whereby anextension portion 202 of device 200 is shown positioned within at leastpart of folder 404 and a flange portion 204 of device 200 is positionedwithin at least part of a sleeve 406 and around hypotube 402 proximallyof folder 404. Sleeve 406, as shown in this exemplary embodiment,slidingly engages hypotube 402 and may be moved in a forward or backwarddirection as indicated by the arrow in the figure. FIG. 6B illustratesan embodiment of system 400 where, instead of having the flange portion204, the device 200 comprises two or more wings 304. Accordingly, inFIG. 6B, the wings 304 of the device 200 are shown in the collapsedposition positioned within at least part of a sleeve 406 and aroundhypotube 402 proximal to folder 404.

In at least one embodiment, device 200 is an autoexpandable metallicstent mounted over a hypotube 402 as shown in FIGS. 6A and 6B. Device200 may be compressed by sleeve 406 and folder 404 such that both theextension portion 202 and the flange portion 204 or the wings 304 (asapplicable) are in their collapsed positions. In at least oneembodiment, at least part of system 400 has a diameter of 7 Fr to 8 Fr(2.3 to 2.7 mm), with an exemplary device 200 having a compresseddiameter of about 1.8 to 2.0 mm.

FIGS. 7A and 7B show exemplary embodiments of at least portions ofsystems for preventing stroke of the present disclosure. While FIGS. 7Aand 7B illustrate an embodiment of the device 200 comprising flangeportion 204, it will be understood that this disclosure is equallyapplicable to any embodiment of the device 200 disclosed herein(including, but not limited to, device 200 comprising wings 304).

As shown in FIG. 7A, an exemplary system 400 comprises hypotube 402 towhich folder 404 is coupled thereto. System 400, as shown in FIGS. 7Aand 7B, further comprises sleeve 406 slidingly engaged around hypotube402. Device 200 may be positioned at least partially within folder 404and sleeve 406 prior to deployment, whereby the extension portion 202 ofdevice 200 may be positioned within at least part of folder 404 in acollapsed position, and whereby the proximal portion (i.e. the flangeportion 204 or wings 304, as applicable) of device 200 may be positionedwithin at least part of a sleeve 406 in a collapsed position (as shownin FIGS. 6A and 6B).

As shown in FIG. 7A, device 200 may be partially deployed as follows.First, and in an exemplary method of positioning a stent within a body,a wire 500 (a guide wire, for example) may be advanced within a body ator near a desired location of device 200 deployment. When wire 500 hasbeen advanced, hypotube 402, along with any portions of system 400coupled to hypotube 402, may be advanced along wire 500 within the body.As shown in FIGS. 7A and 7B, initial advancement of at least a portionof system 400 may comprise advancement of hypotube 402, folder 404,sleeve 406, and device 200 positioned within folder 404 and sleeve 406.

When device 200 has been positioned within a body at or near a desiredposition, sleeve 406 may be withdrawn toward the proximal end ofhypotube 402 (in the direction of the arrow shown in the figure). Thisstep may be performed prior to, during, or after the step of positioningthe distal end of hypotube 402 within a vessel (for example, a vesselbranching off the aortic arch 104). As sleeve 406 is slid toward theproximal end of hypotube 402, the flange portion 204 of device 200 isallowed to expand as shown in FIG. 7A Likewise, in the at least oneembodiment where the device 200 comprises two or more wings 304, slidingthe sleeve 406 toward the proximal end of the hypotube 402 results inthe wings 304 moving to the expanded position shown in FIGS. 3A-3C.While at this step the flange portion 204/wings 304 are deployed, theextension portion 202 remains within the folder 404. Accordingly, theextension portion 202 remains undeployed and does not yet engage oranchor to an arterial wall.

Further deployment of device 200 within a body is shown in FIG. 7B. Asshown in FIG. 7B, and upon movement of folder 404 away from device 200(in a direction shown by the arrow in the figure, for example),extension portion 202 of device 200 may deploy as shown in FIG. 7B. Asfolder 404 is moved away from device 200 (by, for example, advancementof hypotube 402 within a body), extension portion 202 of device 200 isno longer positioned within folder 404, thereby permittingexpansion/deployment of extension portion 202.

FIGS. 8A and 8B show exemplary embodiments of at least a portion of asystem for preventing stroke. In at least one embodiment, system 400comprises a conical dilator 600 slidingly engaged around a hypotube 402coupled to a folder 404. As shown in FIG. 8A, an exemplary conicaldilator 600 may comprise a tapered distal end 602, wherein the tapereddistal end 602 is sized and shaped to engage the inside of folder 404.To engage folder 404, conical dilator 600 may slide along hypotube 402in a direction indicated by the arrow in FIG. 8A. An exemplaryembodiment of the engagement of conical dilator 600 and folder 404 isshown in FIG. 8B.

Engagement of conical dilator 600 with folder 404, as shown in FIGS. 8Aand 8B, may facilitate the removal of at least a portion of system 400from a body after positioning device 200. For example, and as shown inFIGS. 7A and 7B, after deployment of device 200 within a body, theportion of system 400 comprising folder 404 is positioned, for example,further within a vessel than device 200. Removal of the portion of thesystem 400 comprising hypotube 402 and folder 404 would require, forexample, pulling that portion of system 400 back through device 200. Asshown in the exemplary embodiments of FIGS. 7A-8B, folder 404 may, forexample, become caught on device 200 and/or a portion of a body,preventing effective removal of that portion of system 400.

In at least one embodiment, and by engaging folder 404 with conicaldilator 600, folder 404, along with the portion of system 400 coupled tofolder 404, may be removed from a body after placement of a device 200as shown in FIGS. 9A and 9B. As shown in FIG. 9A, and after a device 200has been deployed, a user of system 400 may slide a conical dilator 600along hypotube 402 in a direction indicated by the arrow. Conicaldilator 600, in the example shown in FIGS. 9A and 9B, is sized andshaped to fit within the spaces between convex struts 212 of device 200.After conical dilator 600 has engaged folder 404, as shown in FIG. 9B,when hypotube 402 is withdrawn from the body in a direction indicated bythe arrow, folder 404 is also removed from the body without becomingcaught on device 200.

In at least one embodiment of a system for preventing stroke of thepresent disclosure, system 400 comprises a device 200, a hypotube 402,and a folder 404 coupled to hypotube 402 at or near the distal end ofhypotube 402. Device 200, in at least one embodiment, may beautoexpandable, i.e. device 200 has a “memory” allowing it to expand toa native configuration after being retracted/compressed to fit within,for example, folder 404 and sleeve 406. System 400, in at least oneembodiment, may further comprise, or be used in connection with, afemoral catheterization kit known and used in the marketplace.

Now referring to FIG. 14, at least one method of preventing stroke willnow be described using the components of the previously describedsystems for reference and explanatory purposes. Primarily, at step 1402,the device 200 is positioned within a body. In at least one exemplaryembodiment of the present disclosure, the percutaneous placement of thepercutaneous carotid emboli rerouting device (device 200) may beperformed in an angiography procedure room. Prior to positioning device200 at step 1402, a user may optionally perform a contrast aortogram,for example, to map out the aortic arch 104 and where the cerebralvessels merge with aortic arch 104 (optional step 1401). For safety,patient preparation and sterile precautions are recommended as for anyangioplasty procedure.

In at least one embodiment of the method 1400 for preventing stroke, theoptional step 1401 of the method 1400 additionally or alternativelycomprises performing a percutaneous angiogram using technique(s) knownin the art under local anesthesia. As referenced above, the percutaneousangiogram maps the aortic arch 104 so that a user of a device 200 and/orsystem 400 of the present disclosure can, for example, select anappropriately-sized device 200 and/or system 400 (or portion(s) thereof)when performing the procedure.

At step 1402, to facilitate positioning the device 200 within a body, auser may introduce a wire 500 (such as guide wire as shown in FIG. 7A)to reach the innominate artery 114 and/or the left common carotid artery116. After wire 500 has been positioned, portions of system 400 may bemounted over the guide wire 500 and progressed to the level of theentrance of the innominate artery 114 and/or the left common carotidartery 116. Said portions of system 400 may include hypotube 402 and afolder 404 distally mounted thereto, and may further comprise a sleeve406, wherein an exemplary device 200 may be positioned at leastpartially within folder 404 and sleeve 406, as shown in FIG. 10A. Afterthe device(s) 200 are properly positioned at step 1402, the method 1400advances to step 1404 where the device(s) 200 are deployed.

Deployment of device 200 at step 1404, in an exemplary embodiment of amethod of the present application for performing the same, is as afollows. Under fluoroscopy, sleeve 406 may be pulled back to allow thedelivery of the proximal portion of the stent (the flange portion 204 orwings 304 of device 200) as shown in FIG. 10B. The diameter of flangeportion 204 or wings 304 that exceeds the diameter of the innominateartery 114 and/or the left common carotid artery 116 impedes theprogression of device 200 within said arteries, thus giving theuser/operator time to deliver and anchor the second portion of the stent(the extension portion 202 of device 200) by, for example, forwardprogression of hypotube 402 as shown in FIGS. 7B and 10C. In addition topreventing the device 200 from progressing within the artery, when theflange portion 204 and/or wings 304 are expanded upon delivery to theartery of interest, such structures also provide support over the aorticwall of the aortic arch 104 at the level of proximal aortic ostium inwhich the device 200 is deployed.

In at least one embodiment, deployment of the device 200 at step 1404may be facilitated through the use of radiopaque markers 214. Where thedevice 200 comprises radiopaque markers 214, prior to anchoring theextension portion 202 of the device 200, such markers 214 can be used toassist with ensuring proper alignment. Specifically, the user/operatorcan visualize the radiopaque markers 214 through fluoroscopy or othertechnology and rotate the device 200 accordingly so that the convexstruts 212 are positioned as desired relative to the direction of bloodflow within the aortic arch 104. In this manner, the radiopaque markers214 can facilitate placement and orientation of the device 200. Invarious embodiments, device 200 can be positioned approximatelyperpendicular to, or in a direction of (i.e. approximately parallelwith), or in an oblique manner relative to, blood flow in the aorticarch 104, and can even be positioned/deployed in an oblique manner (notparallel or perpendicular), should such a deployment be desired.

When device 200 has been positioned at step 1402 and deployed at step1404, the method 1400 may advance to step 1406 where the hypotube 402and folder 404 are removed from the body, for example, by introducingconical dilator 600 as described herein. In at least one example, thetapered distal end 602 of conical dilator 600 is advanced until itengages folder 404 of hypotube 402, as shown in FIGS. 8A-9B, 10D and10E, effectively forming a single unit (conical dilator 600+hypotube402+optionally wire 500 (not shown)). This “unit” may then removedthrough the convex struts 212 as shown in FIG. 10E, and distally to thefemoral artery for which at least part of system 400 was initiallyintroduced.

Now referring to FIGS. 11-13B, an exemplary system 700 for preventingstroke of the present disclosure is shown. At times, temporary placementof the devices 200 disclosed herein may be desired (as opposed tochronic or permanent placement). In such cases, it is necessary toretrieve the device 200 from the patient after a prescribed period oftime has elapsed or other indications are observed. System 700 comprisesa retrieval system for use in retrieving one or more devices 200previously positioned within an artery extending from the aortic arch104.

System 700 comprises a sleeve catheter 702, a retrieval device 704, andat least one device 200. The sleeve catheter 702 is configured forintravascular insertion and advancement, and comprises an open distalend 708, a proximal end 710 (see FIG. 11C), and a lumen 712 extendingtherebetween. The retrieval device 704 is slidably disposed within thelumen 712 of the sleeve catheter 702 and comprises a proximal end (notshown) for manipulation by a user/operator and a distal end 706configured for advancement through the open distal end 708 of the sleevecatheter 702. The distal end 706 of the retrieval device 704 furthercomprises one or more attachment portions 714 positioned thereon, eachof which are configured to engage the at least one device 200.

The retrieval device 704 may comprise any configuration suitable forslidably advancing through the lumen 712 and through the open distal end708 of the sleeve catheter 702. It will be appreciated that the specificconfiguration of the retrieval device 704 and its one or more attachmentportions 714 can be selected and/or adapted to correspond with theconfiguration of the device(s) 200 to be retrieved. For example, in theembodiments shown in FIGS. 11A-12, the retrieval device 704 isconfigured to retrieve a device 200 comprising two or more wings 304and, thus, comprises one or more wires. Alternatively, in the embodimentof FIGS. 13A and 13B, the retrieval device 704 comprises an elongatedcatheter having one or more attachment portions 714 configured to engageeither the wings 304 or the flange portion 204 (as applicable) of thedevice 200. Furthermore, the proximal portion (the wings 304 or theflange portion 204, as applicable) of the device 200 may be additionallyconfigured to engage or receive the attachment portion(s) 714 of theretrieval device 704.

Now referring back to FIGS. 11A-11C, an embodiment of a system 700 forretrieving at least one device 200 having two or more wings 304 isshown. This embodiment of the system 700 has a retrieval device 704comprising one or more wires slidably disposed within the lumen 712 ofthe sleeve catheter 702. Each of the wires of the retrieval device 704of this embodiment comprises an attachment portion 714 configured tosecurely grab at least one of the wings 304 of the device 200. Forexample, an attachment portion 714 may be curved or comprise a hookcapable of grabbing one of the wings 304 of the device 200.Alternatively, the attachment portion 714 may comprise a screw shape orany other configuration capable of securely grabbing at least one of thewings 304 of the device 200.

While the number of wires of the retrieval device 704 may correspondwith the number of wings 304 present on the device(s) 200 to beretrieved, it will be recognized that the retrieval device 704 maycomprise any number of wires. For example, in the event the retrievaldevice 704 comprises more wires than the number of wings 304 present onthe device(s) 200 to be retrieved, more than one wire may be attached toa single wing 304 and/or any extra wires may remain unattached.Conversely, in the event the retrieval device 704 comprises fewer wiresthan the number of wings 304 present on the device(s) 200 to beretrieved, the available wires may be strategically attached to thewings 304 such that a sufficient amount of force can be exerted on eachdevice 200 to move it to the collapsed position and thus disengage thedevice 200 from the aortic and arterial walls.

FIG. 12 shows the system 700 as applied to two devices 200 positionedwithin the innominate artery 114 and the left common carotid artery 116,respectively. In this embodiment, each of the devices 200 comprisesthree wings 304 and the retrieval device 704 comprises six attachmentportions 714 (here, shown as wires). As such, each wire of the retrievaldevice 704 corresponds with and is attached to one wing 304 of a device200. It will be appreciated that a user/operator can manipulate thewires as a whole (thus manipulating both devices 200 concurrently) or,alternatively, manipulate the two devices 200 independently byidentifying and maneuvering only those select wires that correspond witheach independent device 200.

While FIGS. 11A-12 illustrate embodiments of the system 700 comprising aretrieval device 704 having wires, the retrieval device 704 of thesystem 700 may comprise any configuration suitable for slidablyadvancing through the lumen 712 and the open, distal end 708 of thesleeve catheter 702. Furthermore, the configuration of the one or moreattachment portions 714 of the retrieval device 704 can be selectedand/or adapted to correspond with the configuration of the device 200 tobe retrieved. FIGS. 13A and 13B show two non-limiting examples of suchalternative embodiments of a retrieval device 704. In these embodiments,the retrieval device 704 comprises an elongated catheter having anattachment portion 714 on or near its distal-most end. Likewise, theproximal portion (flange portion 204 or wings 304, as applicable) of thedevice 200 may be configured to correspond with the attachment portion714 of the retrieval device 704. For example, in the embodiment shown inFIG. 13A, the attachment portion 714 of the retrieval device 704 definesa cavity having female threads disposed therein and a magnet 716, whilethe flange portion 204 of the device 200 comprises a correspondingportion 718 having male screw threads and a magnet. Similarly, FIG. 13Bshows an embodiment where the attachment portion 714 of the retrievaldevice 704 comprises a lace and the corresponding portion 718 of theflange portion 204 comprises a corresponding hook tip. Accordingly, ineach of the aforementioned embodiments, the device 200 may be easilyengaged by the attachment portion 714 of the retrieval device 704.

After the attachment portion 714 of the retrieval device 704 is securelycoupled with the device 200 (via the corresponding portion 718 orotherwise), a user/operator can manipulate the proximal end (not shown)of the retrieval device 704 and thus manipulate the device 200. In thismanner, a user/operation may move a device 200 positioned within anartery extending from the aortic arch 104 to its collapsed position and,thus, disengage the device 200 from the aortic and arterial walls.

In the embodiments shown in FIGS. 11A-11C, moving the device 200 fromthe expanded/anchored position to the collapsed/disengaged position isaccomplished by pulling the distal end/attachment portion 714 of theretrieval device 704 toward the proximal end 710 of the sleeve catheter702, thereby applying pressure to the device 200 in the direction of thearrow shown in FIG. 11B. Due to the configuration of the wires of theretrieval device 704, moving the retrieval device 704 in a proximaldirection applies pressure to the wings 304 and pulls them from theexpanded position to the collapsed position. As the wings 304 arecoupled with the extension portion 202 of the device 200, this motiontranslates to the extension portion 202 as well, thereby causing theentire device 200 to move to a collapsed position and disengage theaortic and arterial walls. After the device 200 is disengaged, theretrieval device 704 (and thus the collapsed device 200) is thenslidably removed from the sleeve catheter 702 and the patient's body.

The various devices, systems, and methods for preventing stroke of thepresent disclosure have various benefits to patients with variousdiseases and/or disorders of the heart and/or circulatory system. Forexample, patients with chronic atrial fibrillation (non-valvular atrialfibrillation), recurrence transient ischemic attack, atrial fibrillationand anticoagulation contraindications, and/or left atrial appendagethrombosis may have their risk of stroke either reduced or eliminated byway of an exemplary devices, systems, and/or method of the presentdisclosure. In addition, patients with acute myocardial infarct withleft ventricular thrombus, atrial flutter (ablation and pulmonary veinisolation), cardiomyopathy with left ventricular enlargement,non-obstructive thrombus of a mechanical heart valve, patent foramenovale (cryptogenic ischemic stroke) and/or an acute infectionendocardiatis with valve vegetation without valve insufficiency undermedical treatment (vegetation >1 cm which currently oblige to surgicalremotion) may also benefit from the present disclosure.

Furthermore, it is noted that the various devices, systems, and methodsfor preventing stroke of the present disclosure have advantages ascompared to anticoagulant and antiplatelet therapies, as not allpatients are suitable for such therapies (given the high risk ofbleeding, for example), and the relative cost of such therapies, whichwould be substantially higher as compared to the devices and systems asreferenced herein. The various devices and systems would be useful forvarious aortic arch configurations, noting that there is diversity amongarches.

While various embodiments of devices, systems, and methods for theprevention of stroke have been described in considerable detail herein,the embodiments are merely offered by way of non-limiting examples ofthe disclosure described herein. It will therefore be understood thatvarious changes and modifications may be made, and equivalents may besubstituted for elements thereof, without departing from the scope ofthe disclosure. Indeed, this disclosure is not intended to be exhaustiveor to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

1. A stroke prevention device, the stroke prevention device comprising:an extension portion having a first end and a second end, the extensionportion sized and shaped to fit within an artery extending from anaortic arch; an anchor portion comprising a plurality of wings coupledwith the second end of the extension portion, the anchor portion sizedand shaped to prevent the stroke prevention device from advancing intothe artery extending from the aortic arch in which the first end of theextension portion may be positioned and each comprising a firstattachment portion; and two or more parallel convex struts positionedacross an opening defined within the second end of the extensionportion, the two or more parallel convex struts configured to divert anembolus from entering the artery when the first end of the extensionportion is positioned within the artery; wherein the first attachmentportion of the anchor portion of the stroke prevention device isconfigured to be engaged by an attachment portion of a retrieval deviceto remove the stroke prevention device from the artery.